Actigall

Product NDC: 0023-6145
Requested package NDC: 0023-6145-01
11-digit product format: 000236145
Labeler code: 0023
Product ID: 0023-6145_9235c1d8-4038-475c-9962-bbf988d600c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA019594
Marketing category: NDA
Marketing start: 1987-12-31
Marketing end: 2021-09-30
Substance: URSODIOL
Active strength: 300 mg/1
Pharmacologic classes: Bile Acid [EPC],Bile Acids and Salts [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0023-6145	0023-6145-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019594-001	ACTIGALL	URSODIOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31
N019594-002	ACTIGALL	URSODIOL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019594-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019594-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019594-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019594-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019594-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019594-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019594-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019594-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019594-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019594-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019594-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019594-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019594-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019594-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019594-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019594-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019594-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019594-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019594-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019594-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019594-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019594-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019594-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019594-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019594-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019594-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019594-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019594-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019594-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019594-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019594-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019594-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019594-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019594-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019594-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019594-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019594-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019594-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019594-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019594-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019594-002	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-6145-01	EA - Each	0023-6145	bbd064ee-dfe7-4a14-a1d0-a6644003ffb7	1	2019-04-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	AvKARE	00c47258-aef0-53f6-e063-6294a90af96f	2026-01-19	Adverse reactions	Exact identifier application applno (NDA): 019594 application number: NDA019594
Ursodiol	URSODIOL	Actavis Pharma, Inc.	a061bb07-a85d-4b08-877f-ce02156f0de7	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019594 application number: NDA019594

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
724L30Y2QR	URSODIOL	128-13-2	URSODIOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-6145-01	00023614501	100 CAPSULE in 1 BOTTLE (0023-6145-01)	100 capsule	1987-12-31	2021-09-30	No	No	Current